Cardiovascular assist device

ABSTRACT

A cardiovascular assist device for producing an inwardly orienting pulsating pressure circumferentially to the entire length of each extremity of a patient, including a main body portion surrounding the extremity and a lateral body portion being inflatable to tightly constrict the main body portion about the extremity before pulsation. The lateral body portion includes a single inflatable tube having connecting tapes extending substantially entirely circumferentially therearound and oppositely circumferentially at least partially around said main body portion to terminal ends secured to the main body portion. The main body portion includes an outer restraint material reinforced by a plurality of circumferentially extending and a plurality of longitudinally extending restraint tapes, two sheets of resilient material circumferentially bonded together at longitudinal intervals and longitudinally along seams to produce a plurality of overlapping circumferentially extending inflatable bladders, which are longitudinally spaced from each other, an inner pouch material and a plurality of fluid couplings communicating with each bladder and inflatable tube. Mittens are provided to close one end of each main body portion and similarly constructed to provide an inwardly pulsating pressure to the respective hand or foot of the patient. The main body portions and mittens may be donned and doffed by means of respective longitudinally extending fasteners, and thereafter manually circumferentially constricted by means of longitudinally extending lacings prior to the pressure constriction caused by inflating the lateral body portion.

United States Patent f 1151 3,659,593

Vail [451 May 2, 1972 [541 CARDIOVASCULAR ASSIST DEVICE 51 ABSTRACT [72]Inventor; Edwin Va, 20 whitcomb Drive, -A cardiovascular assist devicefor producing an inwardly sbury Conn 06070 orienting pulsating pressurecircumferentially to the entire length of each extremity of a patient,including a main body Flledi p 20, 1970 portion surrounding theextremity and a lateral body portion being inflatable to tightlyconstrict the main body portion about the extremity before pulsation.The lateral body portion includes a single inflatable tube havingconnecting tapes ex- [21] Appl. No.: 30,136

[52] 0.8. CI ..128/64 tending Substantially entirely circumferentiallylhereawund 51 lm. Cl. ..A61h 7 00 and pp y circumferentially at leastPartially around said 58 Field 01 Search ..128/24, 64, 87, DIG. 20 mainy portion to terminal ends secured to the main y portion. The main bodyportion includes an outer restraint material reinforced by a pluralityof circumferentially extend- [56] References Cited ing and a pluralityof longitudinally extending restraint tapes, two sheets of resilientmaterial circumferentially bonded UNITED STATES PATENTS together atlongitudinal intervals and longitudinally along seams to produce aplurality of overlapping circumferentially extending inflatablebladders, which are longitudinally spaced from each other, an innerpouch material and a plurality of 2,781,041 2/1957 Weinberg ..128/24UX2,379,497 7/1945 Sellmeyer.... ....l28/24X gzxz g fluid couplingscommunicating with each bladder and inflata- V H ble tube. Mittens areprovided to close one end of each main body portion and similarlyconstructed to provide an inwardly FOREIGN PATENTS OR APPLICATIONSpulsating pressure to the respective hand or foot of the patient. Themain body portions and mittens may be donned and 483,] l l Great Br ta ndoffed means f respectivelongitudinally extending 1,171,361 1 H1969Great Britain ..l28/DIG. 2Q fasteners and thereafter llcircumferentially stricted by means of longitudinally extending lacingsprior to H 1 th I t Primary Emminer L- w. pp ghoitpgplssure constrictioncaused by in a ing e a eral body Attorney-Krafft and Wells 23 Claims, 12Drawing Figures M 4o 40 [I Patented y 1972 5 -Sheet 1 mvsmon DWIN G. VAIL FIG. 1

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Patented May 2, 1972 5 Sheets-Sheet z FIG. 3

mvnrwon EDWIN G. VAI L ATTORNEYS Patented May 2, 1972 5 Sheets-Sheet 5ATTORNEYS Patented May 2, 1972 5 Sheets-Sheet 4 Y/I II" LII IlIll l'IIIIIIIIIII II mvzrwon EDWIN G. VAI L CARDIOVASCULAR ASSIST DEVICEBACKGROUND OF THE INVENTION In the past, various devices have beenconceived to compress a single extremity of the human body as a means oftreating varicose veins, skin ulcers, flaccid muscles, and the like.None of these devices has been configured and integrated in a mannerwhich is considerate of the total body physiology and body surface arearequired to efiectively mechanically pump blood to reduce the work ofthe heart of sequentially compressing the arteries and veins of all theextremities, concurrently. It is one thing to apply pressure andsuddenly release it on part of an extremity, but to be effective, anexternal cardiovascular assist device must be sequence pulsated over allextremities, concurrently, with each pulse sequence being keyed by thepatients electrocardiogram to effectively augment the arterial pulsewave in the arterial system. Further, none of the past devicesconsidered the integrated structural means, using textile-typematerials, essential in assuring pulsating pressures high enough toincrease the aortic pulse pressure while concurrently augmentingarterial and venous blood flow.

SUMMARY It is the purpose of this invention to describe the means forthe structural integration of pressure zones required in an externalcardiovascular assist device for reducing the work of the heart andwhich is easily operable by physicians, nurses, ambulance technicians,and the like.

The structural means for this device are capable of transferring highpressure (up to p.s.i. or more) to the human extremities with a minimumloss of mechanical advantage within the pressurizing materials of thecuff assemblies. The sequence pulsating cuff assemblies encompass,concurrently, all extremities of the human body, extending from the armpits to enclose the tips of the fingers, and from the groins to enclosethe tips of the toes.

Another objective of this invention is to utilize the humanphysiological responses to eternal mechanical stimulation in thepressure receptors located in the aortic arch and the resultingsequences of autonomic reflex action which, when stimulated by anincrease in aortic pressure, reflexively slow the heart rate and reducethe strength of contraction of heart muscle. It is known that if thework of the heart is reduced by 25-30 percent, collateral blood vesselswill open within cardiac muscle and will fill with blood during anincrease in the testing phase of the cardiac cycle. The establishment ofthis collateral cardiac circulation can prevent or reduce cardiacinfarction which may result from an occlusion of a coronary artery.

High external mechanical pressure is applied, concurrently andsequentially, to all the extremities of the human body in propersequence with the patients electrocardiogram and cardiac cycle to raisethe aortic pulse pressure after the aortic valves haveclosed. Thismechanical increase in the aortic pulse pressure stimulates the aorticpressure receptors, which in turn reflexively activate the autonomicreflex arch through the autonomic nervous system and thence to the heartto slow the heart rate, reduce the strength of heart muscle contraction,and increase the relaxation phase of each cardiac cycle. Concurrently,with each sequence pulsation of the cuff assemblies there is an increaseof venous blood flow back to the heart.

The fully integrated parts will increase the mechanical advantage ofcuff assemblies constructed of textile-type materials. The integratedstructure described herein has been developed to overcome the stretch(8-19 percent of nominal length) inherent in various textile-type fabricmaterials when acted upon by high applied pressures. This structuralintegration is essential and a novel feature of this invention since noindustry has as yet produced a nomelastic flexible fabric .of a strengthwhich wont stretch under high pressure loads. The failure of pastconcepts to be effective has been due to a disregard of the losses ofmechanical advantage in force transfer which results from a looseunsupported construction and a lack of integration of all componentparts in each cuff assembly. A laterally located tube is connected tothe restraint material by interlapping tapes so that expansion of thelateral tube on inflation fully stretches the outer restraint materialto its maximum stretch to increase the effective transfer of force fromthe pulsating pressure, inwardly, applied within each pressure bladderzone of each cuff assembly, concurrently, during operation on allextremities of the human body. Positive control of the bladder volume ineach pressure compartment of each zone is obtained while maintaining amaximum of applied force from pulsating pressures applied to thearteries and veins within each bladder zone of each cuff assembly,concurrently, during operation on all extremities of the human body.Circumferential structural support is attained adjacent to each pressurezone of each bladder compartment of each cuff assembly, concurrently,during operation on all extremities of the human body.

Means are provided for removing all slack from the restraint cloth byestablishing a pre-stretch condition throughout the entire length ofeach cuff assembly prior to the application of pressure in the laterallylocated tubes to assure that all restraint materials will be fullypre-stretched, before maximum stretch is accomplished on pressurizationof the lateral tubes and prior to sequential pulsation operation on allextremities of the human body. Rapid donning and doffing of each cuffassembly is obtained by the proper structural integration of zippers,Velcro, or similar type closures without affecting the pressureintegrity or mechanical efficiency of operation (restraining forcepressures up to 10 p.s.i. or more) of each cuff assembly in maintainingthe restraint cloth in a fully stretched condition, and maintainingstructural and mechanical function during sequential pulsation operationon all extremities of the human body.

Means are provided for introducing high pressures (up to 10 p.s.i. ormore) into the bladder compartments for each zone of each cufi assembly,concurrently and sequentially, while maintaining the structuralintegrity of the adjacent restraint cloth and bladder material duringsequential pulsation operation on all extremities of the human body.

The structural arrangement of the bladder compartments of each zone ofthe cuff assembly includes an overlapping segment of sufficient area toassure that the pressure compartments of each zone fully encompass thecircumferential dimensions of all extremities of the human body and thatthe said extensions of each bladder compartment fully underlie theentire length of the closure device, thereby assuring that allpulsatingpressures are equally applied to the entire circumferential area of allextremities of the human body, concurrently, throughout the entirelength of each cuff assembly. An independent compartment in each bladderzone of each cuff assembly is provided in a proper relationship with therestraint cloth and of sufficient extent and area to encompass theentire circumference and underlie the entire length of the closuredevice, while concurrently maintaining a minimum bladder volume, yetassuring a maximum of applied force inwardly to the arteries and veinswithin each bladder zone of each cuff assembly, concurrently, duringoperation on all extremities the human body.

Sequence pulsation pressure is applied concurrently to the hands andfeet in proper sequence as a functional zone with each cuff assembly forall extremities of the human body. The slack from the restraint cloth isremoved throughout the entire length of each mitten assembly prior tothe application of pulsation pressure to assure that all restraintmaterial of the mitten assemblies is fully pre-stretched prior to theapplication of pressure loads. The pressurizable mittens have positivemeans for controlling the bladder volume and a means for providing arigidized integral support structure to the palm, while maintaining amaximum of applied force (up to 10 p.s.i. or more) from pulsatingpressure to the arteries and veins of the hand, concurrently, duringoperation on all upper extremities of the human body. Rapid donning anddoffing of the mittens is provided by a proper structural integration ofzipper, Velcro, or similar type closures without affecting the pressureintegrity or mechanical efficiency of operation of each mitten of eachupper extremity cufi assembly in maintaining the restraint cloth in apre-stretched condition and maintaining structural and mechanicalfunction during sequence pulsation operation on all upper extremities ofthe human body. High pressure (up to p.s.i. or more) is introduced intothe mitten bladder compartment, concurrently and sequentially, whilemaintaining the structural integrity of the adjacent restraint cloth andbladder material during sequence pulsation operation on all upperextremities of the human body.

Pressurizable boots are provided with means for removing all slack fromthe restraint cloth of each boot assembly prior to the application ofpressure to assure that all restraint material of said boots is fullyprestretched prior to the applica tion of pressure loads. Thepressurizable boots include positive means for controlling the bladdervolume and a means for providing a rigidized integral support structureto the sole of the foot, while maintaining a maximum of applied force(up to 10 psi. or more) from pulsating pressures applied to the arteriesand veins of the foot, concurrently, during operation on all lowerextremities of the human body. Rapid donning and doffing of thepresurrizable boots is attained by a proper structural integration ofzippers, Velcro, or similar type closures without afiecting the pressureintegrity or mechanical efficiency of operation of each boot of eachlower extremity cuff assembly in maintaining the restraint cloth in apre-stretched condition and maintaining structural and mechanicalfunction during sequence pulsation operation on all the lowerextremities of the human body. High pressure (up to 10 p.s.i. or more)is introduced into the boot bladder compartment, concurrently andsequentially, while maintaining the structural integrity of the adjacentrestraint cloth and bladder material during sequential pulsationoperation on all lower extremities of the human body.

Means, for example a slot or slit, are provided in the cufi' assembliesfor the upper extremities, structurally re-enforced with restraint tapeand located at the proper level of the inner surface of the elbowbetween pressure zones and within the circumferential restraintstructure, to enable the physician to insert cardiac catheters or thelike into the arteries or veins of the patient as may be required in theclinical evaluation of the patient without interfering with thestructural integrity or the mechanical efficiency and the effectivetransfer of force from the pulsating pressures within adjacent bladderzones of each cuff assembly, concurrently, during operation on all upperextremities of the human body.

The complete structural integration of all materials in the constructionof this cardiovascular assist device will minimize and/or eliminate theeffect stretching of textile-type materials has in reducing forcetransfer as each zone of each cuff assembly is pressurized, and therebyincrease the total effective mechanical force applied inwardly to thearteries and veins in each zone, assuring a more effective mechanicalpumping pressure acting on the blood in the arteries and veins.

BRIEF DESCRIPTION OF THE DRAWING Further objects, features andadvantages of the present invention will become more clear from thefollowing description of a preferred embodiment shown in the drawing,wherein:

FIG. 1 is a full view of the total cardiovascular assist device applied,concurrently, to all the extremities of the human body;

FIG. 2 is a cross section of a cuff assembly taken on line II II of FIG.1, shown in an expanded view to reveal the intimate relationships forthe integration of all component parts as arranged around each extremityof the wearer;

FIG. 3 is an enlarged cross-sectional view of the high pressure lineconnection shown in FIG. 2;

FIG. 4 is an enlarged crosssectional view taken on line IV- IV of FIG. 1showing a catheter slot or slit;

FIG. 5 is a cross-sectional view taken on line V-V of FIG. 1 showing theanchoring of the restraint cloth, bladder material and pressure pouchmaterial;

FIG. 6 shows a modification of the FIG. 5 structure;

FIG. 7 shows the means for providing overlap of each pressure zonecompartment throughout the length of each cuff assembly in the enlargedcross section taken essentially on the line VII-VII of FIG. 1;

FIG. 8 shows the means for removing all slack material from each cufiassembly before application of pressure in the lateral pressure tube asshown in the enlarged cross section taken essentially on the lineVII-VII in FIG. 1, with the lacings closed; FIG. 9 shows the lateralpressure tubes and the interlapping tapes that provide the means ofmaximally stretching the restraint cloth in cross section takenessentially on line IX-IX as seen in FIG. 1;

FIG. 10 shows the essential details of a pressurized boot, which issubstantially identical to the pressurized mitten except for the angularrelationship between the wrist and ankle;

FIG. 11 is an enlarged cross section of the pressure boot, takenessentially on line XIXI as seen in FIG. 10; and

FIG. 12 is a partial cross section of a modification of the FIG. 1 1structure.

DETAILED DESCRIPTION OF THE INVENTION As shown in FIG. 1, thecardiovascular assist device of the present invention includes one ormore, with four being shown, cuff assemblies 1, each of which isdesigned to encompass an extremity of the body, for example, the armsand legs. Preferably, each cuff assembly 1 is tubular in shape with itsouter extremity end being closed and its opposite end being open. Thetwo cuff assemblies for the two arms of the wearer may be identical ormirror images of each other. Similarly, the two cuff assemblies for thetwo legs of the wearer may be identical or mirror images of each other.Further, the basic structural features for the leg cuff assemblies andthe arm cuff assemblies are correspondingly identical, except that thereis an angular relationship at the ankle portion of each leg cuffassembly, because of the correspondingly different angular relationshipbetween the ankle and wrist of the intended wearer. For this reason,only one cuff assembly will be described in detail with theunderstanding that there, is a correspondance between the cuffassemblies.

Each cuff assembly 1 includes a main body portion 2 and a lateral bodyportion 3, which are cooperatively held with respect to each other bymeans of interlooping or crossing interconnecting tape connectingmembers 4. The main body portion 2 is provided with a releasableclosure, 5 preferably interengaging, for example Velcro, a zipper, orsnaps, which extends from the open end down to the wrist or ankle area,respectively, so that the main body portion may be laid open for easyinsertion of the wearers extremity. The insertion of the extremity isfurther facilitated by means of reclosable fasteners, for exampleVelcro, zippers or snaps, 6 (not shown in FIG. 1) on their respectivehand or foot mittens 7. The easy donning or doffing of the cuffassemblies by the wearer is particularly enhanced by the above featuresand important in view of the anticipated convalescent condition of'thewearer, for example if the wearer is in a coma resulting from a heartattack. Each mitten 7 is peripherally secured to the adjacent tubularstructure of the main body portion and their respective fasteners may ormay not be aligned.

Due to the difi'erent size extremities to be encountered with differentwearers, the slack in the main body portion 2 existing after thefasteners 5 and 6 have been closed in taken up as much as possiblemanually by means of a lacing 8 extending parallel to and for the fulllength of each fastener 5, 6. It is important to take up this slackbecause the interior of each main body portion, including mitten 7,contains an inflatable structure for receiving pulsed air forcardiovascular assist, which pulsing is known per se. More efficienttransfer of pulsing pressure and a quicker response time is obtainedcorrespondingly with a tighter fit for each main body portion 2.

Before the pulsing begins, but after the donned cuff assembly has beenmanually tightened by means of the lacings 8, further slack ismechanically taken out of the main body portions by means of inflatingthe lateral body portions to apply a force through the connecting tapemembers 4 to tightly constrict the main body portions about the wearer'sextremities. For this purpose, high pressure air inlet nipples 9 areprovided for access to the inflatable interior of each lateral bodyportion 3.

Thereafter, known high pressure air pulsating equipment, which will notbe described in detail in this application, is fluid connected by meansof the fluid couplings 10 to the inflatable interior of each main bodyportion 2.

The somewhat schematic representation in FIG. 2 shows the over-allarrangement of the various components in cross section, which componentswill be shown in more detail in subsequent figures with more detailedexplanation. The extremity ll of the wearer is directly contacted by asuitable pouch material 12 which may be cotton, nylon, or the like.Surrounded by the pouch material 12, there is an overlapping inflatablebag structure 13, which overlaps as shown at its ends 14 beneath thefastener 5. The tape connecting members 4, as seen in FIG. 2, extendfrom the lacing 8 counterclockwise approximately one-fourth of the wayaround the main body portion 2, between the main body portion 2 and thelateral body portion 3, clockwise substantially the entire way aroundthe lateral body portion 3, between the main body portion 2 and thelateral body portion 3, and counterclockwise for less than one-fourth ofthe way around the main body portion 2 to its free terminal end 15 whereit is secured to the main body portion 2. Thus, it' is seen that thetapes 4 extend between the main body portion 2 and the lateral bodyportion 3 in the manner of a fugure 8 so that inflation of the lateralbody portion 3 from its full line position to the dotted line position16 will exert a considerable force upon the tape connecting members 4,which will be applied around the entire periphery of the main bodyportion 2 for constricting the main body portion 2 tightly around theextremity ll of the wearer. To assist in the transfer of these forcesand to enclose the bag structure 13, substantially the entire outersurface of the main body portion 2 is provided by an outer layer ofrestraint material 17, which may be cotton, nylon or the like.Preferably, the restraint material 17 is a woven material with the warpand woof oriented at approximately an angle of 108.

One of the couplings 10 is shown in detail in FIG. 3, and issubstantially identical to the structure of the nipples 9. As shown, thecoupling provides fluid access from the exterior through the restraintmaterial 17, and an outer air impermeable wall 18 of the bag structureto the interior of the bag structure for inflating and deflating the bagstructure 13, or the inflatable lateral body portion in the case ofnipples 9. A threaded stem 19 is provided with an inner flange 20, whichone-piece construction may be of metal or like rigid materials. Aplurality of angular gaskets 21 are cemented respectively between theflange and the bag material 18, between the bag material 18 and therestraint material 17, and between the restraint material 17 and a nut22 threaded onto the stem 19. In this manner, the stem 19 is sealinglysecured to the assembly and provided with an outer portion for thereception of a complementarily formed pressure nozzle. The nut willclamp the gaskets and assist the cement in this sealing.

As seen in FIG. 1 and in more detail in FIG. 4, an aperture or slot 23is provided in at least one of the arm cuff assemblies 1 in the regionopposite the elbow, which provides access to the wearers arteries andveins for the insertion or maintenance of cardiac catheters or the like.A physician or technician may insert these catheters while the cuff ison the patient or prior to the cufi assembly being donned for requiredclinical evaluation of the patient, without interfering with thestructural integrity or the mechanical efficiency and effective transferof force from the pulsating pressures within the adjacent bladder zonesof each cuff assembly. If the catheter is inserted into the patientprior to donning of the cuff assembly,

the various tubes may be threaded through the aperture 23 withoutremoval of the catheter during donning of the cufi assembly.

As shown most clearly in FIG. 4, the aperture 23 extends through theouter restraint material 17, both layers of the bag material 18, and theinner pouch material 12. Preferably, ce ment is provided between each ofthese layers so that there is a tight sealing arrangement, particularlywith respect to the two layers of the bag material 18, which must havean airtight seal. For reinforcement of the aperture, a restraint tape 24of suitable strong and thick woven material or the like is provided onall sides of the aperture 23, which restraint tape may be approximatelythree-fourths inches wide and l% inches long To provide a smooth liningfor the aperture 23 between the layers, a binding material 25 extendsover the restraint tape 25, lines the aperture 23 and extends under thepouch material 12 as shown on all sides of the aperture 23. Therestraint tape 24 and binding material 25 may be cemented and/orstitched to the adjacent layers. A suitable method of assembly wouldinclude the cementing and perhaps stitching of he layers 12, 18, 17 and24, the forming of the aperture 23 with a sharp blade or electricburning tool to approximately a length of 1 inch through all of thelayers, and the later cementing and/or stitching of the binding tape 25around the thus formed aperture to prevent fraying and abrasion.

From a comparison of FIGS. 1 and 5, it is seen that each of the cuffassemblies 1 includes a pluralityQparticularly 4 excluding the mittens,of independently inflatable bags or bladders 26, which extendcircumferentially around the wearer's extremity and are axially spacedwith respect to each other. Each of these inflatable bags 26 may beformed by pairs of bag material 18 or by only two sheets of bag material18 for each cuff assembly by providing a cemented seam 27 betweenadjacent bags 26. The bags 26 are anchored adjacent their seams 27 tothe adjacent layers of restraint material 17 and pouch material 12 bymeans of a plurality of anchor tabs 28 that are cemented to theirrespective restraint material 17 or pouch material 12 at one end andcemented at their other end to the adjacent layer of bag material 18.The restraint tape 24 is provided immediately overlying the seams 27 andthe anchor tabs 28 to provide additional reinforcement in this importantarea. Altemately, or in addition, the restraint tapes 24 and anchor tabs28 may be stitched to their respective adjacent materials.

In FIG. 6, there is shown a construction that could be used instead of aconstruction shown in FIG. 5 to form the plurality of separate bags 26.With this modification, the restraint tape 24, the restraint material17', the bag material 18', the pouch material 12, and an over-tape forreinforcement 29 are stitched and/or cemented together. The constructionshown in FIGS. 5 & 6 are necessary to form the separate pressure zonesor bags, for circumferential alignment, and to assure proper bladder orbag positioning and structural support. Thus, positive volume controlfor each pressure zone is obtained by the complete integration of allcomponents as described above. This is accomplished by securelyanchoring all layers of materials one into the other and is essential inpreventing lateral or longitudinal displacement of the pressure zones orbags of all cuff assemblies on the extremities of the wearer as well asto assure the maximum inward direction of mechanical forces duringsequence pulsation operation.

FIG. 7 shows in greater detail some of the structural features that weresomewhat schematically shown in FIG. 2 and on a larger scale. Thefastener 5, which is shown as a zipper,

has its connecting tapes 29 stitched or otherwise secured to theadjacent restraint material 17 and pouch material 12. Furthermore, thestitching will secure the ends of the circumferentially extendingrestraint tapes 24 and extend along the outermost longitudinallyextending restraint tapes 24 for additional reinforcement. It is seenthat the pouch material 12 extends from where it is stitched asmentioned above to the left of the fastener 5, as seen in FIG. 7,downwardly and to the right to end 30 where it is folded back around thesealed edges of the bag material 18 to overlie and protect these edges,

where it is stitched or otherwise secured. The same sheet of material 12may extend back towards the left or an additional sheet of pouchmaterial 12 may be used as shown, which would also be secured at end 30.Similarly, the other terminal edge of the pouch material 12 extends fromwhere it is stitched to the right-hand tape 29 of the fastenerdownwardly and to the right to point 31 where it is stitched or securedto an additional sheet of pouch material 12 that extends back towardsthe left and over its bag material 18. To assure the proper positioningof the last-mentioned two sheets of pouch material 12, an anchor tab 28is secured between the pouch material 12 at point 31 and the adjacentsheet of bag material 18. At securement point 32, the structure issubstantially a mirror image of the structure recited at end 30, with asingle sheet of pouch material 12 extending circumferentially around theextremity of the wearer from edge 32 to end 30.

Also, the lacings 8 are shown in more detail in FIG. 7, wherein the twoparallel lacing tapes 33 are secured by stitching or the like on theright to the restraint material 17, with the interposition of theterminal ends of the circumferentially extending restraint tapes 24, andon the left to the restraint material 17 with the interposition of theterminal ends of the tape connecting members 4. Each of the lacing tapes33 is provided on its edge facing the other lacing tape with a pluralityof loops 34, through which extend the laces 35, in a known manner sothat by adjustment of the laces 35, the lacing tapes 34 may be drawntogether for constricting the restraint material 17 about the wearersextremity. Since the restraint material 17 extends as one piece beneaththe lacings 8, there will be formed slack restraint material at 36 whenthe lacing tapes 34 are drawn together, so that the cuff assemblies aresealed at the lacings.

The structure shown in FIG. 7 provides an overlapping of the pressurebags beneath the fastener 5, which will not only facilitate donning anddoffing of the cuff assemblies 1, but will also assure a continuousoverlap of all pressure zones throughout the entire length of each cuffassembly for all extremities and provides for a uniform application ofpressure to the surfaces of all extremities during sequence pulsationoperation. Structural integrity is further maintained by means ofcircumferentially extending restraint tapes 24 and the longitudinallyextending restraint tapes 24. Direct action and quick response of thepressure pulsations within the pressure zones is assured by the manualtensioning of the restraint cloth 17 through adjusting the laces 35 todraw the lacing tapes 33 toward each other, which will also maintain acontinuous tension on the restraint cloth circumferentially andlongitudinally to, thereby establish a pre-stretched condition for theentire length of the cuff assemblies. FIG. 8 illustrates the manner inwhich the restraint material slacked at 36' will fold tightly 7 underthe pressure exerted by the tensioned cuff assembly against the wearersextremity during tightening the laces 35.

After the laces 35 have been tightened as mentioned above to theconstruction of FIG. 8, the lateral body portions 3 will be inflated toreact through the tape connecting members 4 for further constricting themain body portion 2 about the wearer's extremity. This relationship isshown particularly in FIG. 9. The lateral body portion 3 has alongitudinally extending restraint tape 24, which is stitched to theouter tubular restraint material 37 to securely hold the tape connectingmembers 4 in their proper spacing longitudinally of each other and toprovide structural integrity for the lateral body portion. Within eachlateral body portion 3, there is asingle inflatable tube 38, whichextends the entire longitudinal length of the lateral body portionwithin the tube of restraint material 37. It is thus seen by inflatingthe tube 38, the restraint material 37 will expand to tension all of thetape connecting members 4 and pull additional lengths of tape connectingmembers 4 from the main body portion 2 to further constrict the mainbody portion 2 about the wearers extremity. The size of the inflatabletube 38 is chosen such that its circumference is approximately one-fifththe circumference of the main body portion 2. The functional length ofthe tape connecting members 4 is selected such that maximum expansion ofthe lateral pressure inflatable tube 38 will apply maximum stretchingforce, circumferentially, through the diametrically. opposed integratedanchor of points for the terminal ends of the tape connecting members 4on the main body portion 2. Structural reinforcement of the anchoringpoints is provided by the restraint tapes 24 extending for the entirelongitudinal length of the lateral body portion 3 along the middles ofthe tape connecting members 4 and the main body portion 2 along theterminal ends of the tape connecting members 4. As previously mentioned,each inflatable tube 38 has access to its inflatable interior by meansof a nipple 9 shown in FIG. 1. In this manner, structural integrationand support of all component parts of each cuff assembly is provided, byinterconnection of all restraint material 17, restraint tapes 24,bladder or bag material 18, pouch material 12, fastener 5, tapeconnecting members 4, lacings 8, and the inflatable tube 38. I

A mitten, particularly a foot mitten, is shown in FIG. 10, with likenumerals applied to structural elements that are identical to previouslydescribed structural elements. It is understood that the hand and footmittens are substantially identical, except for the correspondinglyangular difference between the ankle and wrist portions thereof.However, it is seen from FIG. 10 that two lacings 8 are provided, one oneach side of the fastener 5, instead of only one lacing as previouslydescribed with respect to the main body portions 2. Each mitten issecured to the terminal end of its respective main body portion 2, toclose the same.

Specific details of the mittens are shown in FIG. 11, with like numeralsbeing used as mentioned above. The upper portion of FIG. 1 1 issubstantially identical to the structure shown in FIG. 7 with respect tothe details of the fastener 5, lacings 8,

and the overlapping of pouch material 12 and bag material 18 beneath thefastener 5, except that in FIG. 1 1, two lacings are provided.Therefore, for details of the various structural components, referenceis made to the description with respect to FIG. 7, which is equallyapplicable with respect to identical structural components as shown bylike numerals.

Each mitten is provided with a hard sole or palm portion 39,

as the case may be respectively for the foot or'hand. This hard sole 39is covered on each face by means of pouch material 12. The hard sole 39.is constructed of metal, or similar rigid material, and of a sufficientstrength to resist bending during sequence pulsation and therebyincrease the effectiveness of the sequence pulsating bladder 26. Fluidaccess to the bag 26 is provided by means of a fluid coupling (not shownin FIG. 1

11) which is identical to the fluid coupling shown in FIG. 3. It is seenthat all of the terminal ends of the sheet material, except for therestraint tapes 24, are assemblied at the edges of the sole 39 wherethey are sealed by cement and otherwise tightly secured together, withthe outer layer of restraint material 17 being folded around the edgeportions to prevent fraying and abrasion.

A further modification of the sole structure is shown in FIG. 12. Inthis modification, the bag material 18 extends completely across therigid sole 39 and is connected respectively by anchor tabs 28 to theinner pouch material 12 and the outer restraint material 17.

OPERATION It is known physiologically that a pressure gradient exists,inwardly whenever mechanical pressure is applied to the surface of thehuman body. Therefore, it is an important feature of the presentinvention to provide the means for introducing high pressure (up to 10p.s.i. or more) into all pressure zones or individual pressure bags ofthe main body portions and inflatable tubes of the lateral body portionsto assure that adequate mechanical forces are obtained during theoperation of the cardiovascular assist device. Each cuff assembly is soconstructed for each body extremity so that the pulsating forces tendingto increase the circumferential size and longitudinal length by stretchof the fabric-type materials of each pressure zone compartment will beoptimally balanced, one against the other, when pulsating pressures areapplied. In this manner, the maximum restraint characteristics inherentin the weave of the warp and woof of the fabrics, due to the friction ofinterlocking threads within the fabrics, are utilized to resist furtherstretching, when pulsating pressure is applied, by first removing allslack within the restraint cloth by manually tightening lacings toestablish a prestretched condition, and thereafter by mechanicallypre-stressing all of the fabrics with the introduction of high pressurefluid within the lateral body portion inflatable tubes. Maximum stretch,pre-setting the restraint cloth is then obtained through the combinedefforts of the manual lacing and the pressurized lateral body portionsthat apply tension to the main body portions through the tape connectingmembers.

In use of the cardiovascular assist device for encompassing allextremities of the human body concurrently, the manipulative proceduresare as follows. The main body portions with their pressure mittens aredonned first withthe fasteners open and the lacings 8 expanded. Eachhand and foot is appropriately positioned against the hard palm or solesupport structure of the respective mittens. Next, the pressurecompartment flaps are carefully overlapped beneath each fastener, whichfastener is thereafter joined and closed. Afterward, the laces areadjusted to manually take up any slack within the restraint cloth andpre-tension the restraint cloth for each main body portion, includingmittens. The wrist flaps and ankle flaps of adjacent inflatable bags areconfigured such that the arm and leg cuff assemblies, respectively, willoverlap the flaps by approximately 3 or 4 inches. At appropriate pointswithin the preceding donning procedure, any catheters that werepreviously inserted within the patients arteries or veins adjacent theelbow portion of his extremity, are fed through the aperture or slot andthe corresponding cuff assembly, or after donning, the appropriatecatheter is inserted.

Thereafter, the inflatable tube of each lateral body portion isconnected by a suitable pressure coupling to a constant pressure sourceof high pressure fluid to inflate the lateral body portions andcorrespondingly constrict the main body portions.

Each separate pressure zone or bag of each cuff assembly isindependently connected by means of its fluid coupling to the mechanicalsequence pulsating unit (not shown, but conventional). Suitableelectrodes 40 are secured to the wearer in a known manner as shown inFIG. 1 to obtain the electrocardiographic signals required to controland phase the pulsating sequence with each cardiac cycle of the patient.The total cardiovascular assist device applied to all extremities of thehuman body is then ready for sequence pulsation operation. The entiresequence pulsation, simultaneously for all ends or extremities, takesplace within the pressure bladders of each zone concurrently in eachcufi assembly during the time of one heartbeat, at which time pressureis released and the zonal sequence repeated with the next heartbeat.

While several modifications of the preferred embodiment of the presentinvention have been specifically illustrated and described, it isunderstood according to the-broader principles of the present inventionmany modifications, embodiments and variations are contemplated.

I claim:

1. A cardiovascular assist device, comprising: a main body portionadapted to be assembled around the extremity of a patient, and having alongitudinal extent with opposite ends; fluid expandable bladder meanswithin said main body portion for exerting an inward pulsating pressureto the patient corresponding to pulsating fluid pressure supplied to thebladder means; separate fluid expandable chamber means adjacent to andparallel to the longitudinal extent of said main body portion forexpansion in response to fluid pressure supplied thereto to constrictsaid bladder means around the extremity of the patient, closure meansattached to at least one end of said longitudinal extent of said mainbody portion, said closure means including a rigid plate longitudinallyextending along one side and adapted to receive the sole or palm. of thepatient, and bladder means extending around the entire circumference ofthe closure means, said bladder means beingpositioned inwardly of saidrigid plate.

2. The device of claim 1, wherein said main body portion is adapted toextend substantially the full longitudinal length of the patientscorresponding extremity; said expandable chamber means extendingsubstantially the, entire longitudinal length of said main body portion.

3. The device of claim 1, including a plurality of separate connectingtapes, each secured at their opposite ends to said main body portion, toextend from one end partially around said main body portion, betweensaid main body portion and said expandable chamber, reversely aroundsaid expandable chamber, between said main body portion and saidexpandable chamber and partially around said main body portion to itsother end.

4. The device of claim 1, including releasable fastener means extendingfor substantially the full length of said main body portion to permitopening and closing of said main body portion along one entirelongitudinal side for donning and doffing by the patient.

5. The device of claim 1, wherein said main body portion includes lacingmeans extending for substantially its full longitudinal length to permitmanual constriction and expansion of said main body portion bladdermeans.

6. The device of claim 1, including a plurality of said cuff assembliesadapted to be attached to each extremity of the patient.

7. The device of claim 1, wherein said main body portion has an outerlayer of restraint material being substantially more dimensionallystable than said bladder means and extending for the full longitudinallength and full circumference of said main body portion; and a pouchmaterial forming the inside surface of said main body portion andextending for the full longitudinal length and circumference of saidmain body portion.

8. The device of claim 7, including a plurality of restraint tapeslongitudinally spaced with respect to each other and extendingcircumferentially around said main body portion; and a plurality ofadditional restraint tapes circumferentially spaced from each other andextending for the full longitudinal length of said main body portion.

9. The device of claim 1, including slot means permitting I the passageof a catheter radially through said main body portion to the arm area ofthe patient opposite from the elbow; said slot means being a narrowlongitudinally aligned slot extending completely through said main bodyportion.

10. The device of claim 9, including reinforcing means extendingexternally completely around said slot; and binding means extendingcompletely externally around said slot, along all the inner walls ofsaid slot and continuously internally around said slot.

11. The device of claim 1, wherein said closure means includes amitten-type body forming a closure for one end of said body.

12. The device of claim 11, including fluid expandable bladder meansextending at least partially circumferentially around said mitten andlongitudinally'thereof for exerting an inward pulsating pressure to thepatient in response to being supplied pulsating fluid under pressure.

13. The device of claim 11, wherein said mitten has releasable fastenermeans extending for substantially its full longitudinal length.

14. The device of claim 13, wherein said mitten includes lacing meansextending for substantially the full longitudinal length of said mittenand on each side of said releasable fastener means, for manuallyconstricting said mitten in the circumferential direction.

15. The device of claim 11, wherein said mitten includes a rigid platelongitudinally extending along one side and adapted to receive the soleor palm of the, patient.

16. The device of claim 1, wherein said main body portion bladder meansincludes a plurality of sep'rate inflatable bags longitudinally spacedwith respect to each other and each circumferentially extending aroundthe full circumference of the main body portion.

17. The device of claim 16, wherein each of said inflatable bags hasopposed overlapping ends, with the corresponding ends of all inflatablebags being longitudinally aligned; and releasable fastener means forcompletely opening one longitudinal side of said main body portionradially opposite from said overlapping ends of said inflatable bags.

18. The device of claim 16, wherein each inflatable bag includes aseparate fluid coupling; and said expandable chamber means including aseparate fluid coupling.

19. The device of claim 16, including a plurality of longitudinallyspaced and circumferentially extending restraint tapes, with each tapelongitudinally alternating with said inflatable bags.

' 20. The device of claim 16, including restraint materialcircumferentially extending completely around and longitudinally alongsaid main body portion to form its outer surface; pouch materialcircumferentially extending around and longitudinally along said mainbody portion to form its inner surface; a plurality of restraint tapes,each extending circumferentially along the outer surface of saidrestraint material immediately radially opposite the division betweenlongitudinally adjacent inflatable bags; a plurality of binding tapescircumferentially extending around the inner surface of said pouchmaterial directly radially opposite the division between flatable bags.

longitudinally adjacent inflatable bags; each of said inflatable bagsbeing formed of two resilient sheets; respective ones of said restrainttapes, said restraint material, said resilient sheets, said pouchmaterial, and respective ones of said binding tapes beingcircumferentially bonded one to the other at least along a commonradially extending plane.

21. The device of claim 16, wherein each of said inflatable bags isconstructed of only two resilient sheets bonded together alongcircumferential lines forming the division between longitudinallyadjacent bags and together along two longitudinal lines forming saidoverlapping ends.

22. The device of claim 21, including restraint materialcircumferentially and longitudinally surrounding and forming the outerlayer of said main body portion; a plurality of anchor tabs, each havingone end secured to the inner surface of said restraint material and anopposite end secured to a respective one of said inflatable bags; apouch material circumferentially extending and longitudinally extendingto form the inner surface of said main body portion; a plurality ofanchor tabs each having one end secured to a respective one of saidinflatable bags and an opposite end secured to said pouch material; allof said anchor tabs being located immediately radially of the divisionbetween longitudinally adjacent inflatable bags.

23. The device of claim 22,- including a restraint tapecircumferentially extending around said main body portion radiallyopposite each division between longitudinally adjacent in-

1. A cardiovascular assist device, comprising: a main body portionadapted to be assembled around the extremIty of a patient, and having alongitudinal extent with opposite ends; fluid expandable bladder meanswithin said main body portion for exerting an inward pulsating pressureto the patient corresponding to pulsating fluid pressure supplied to thebladder means; separate fluid expandable chamber means adjacent to andparallel to the longitudinal extent of said main body portion forexpansion in response to fluid pressure supplied thereto to constrictsaid bladder means around the extremity of the patient, closure meansattached to at least one end of said longitudinal extent of said mainbody portion, said closure means including a rigid plate longitudinallyextending along one side and adapted to receive the sole or palm of thepatient, and bladder means extending around the entire circumference ofthe closure means, said bladder means being positioned inwardly of saidrigid plate.
 2. The device of claim 1, wherein said main body portion isadapted to extend substantially the full longitudinal length of thepatient''s corresponding extremity; said expandable chamber meansextending substantially the entire longitudinal length of said main bodyportion.
 3. The device of claim 1, including a plurality of separateconnecting tapes, each secured at their opposite ends to said main bodyportion, to extend from one end partially around said main body portion,between said main body portion and said expandable chamber, reverselyaround said expandable chamber, between said main body portion and saidexpandable chamber and partially around said main body portion to itsother end.
 4. The device of claim 1, including releasable fastener meansextending for substantially the full length of said main body portion topermit opening and closing of said main body portion along one entirelongitudinal side for donning and doffing by the patient.
 5. The deviceof claim 1, wherein said main body portion includes lacing meansextending for substantially its full longitudinal length to permitmanual constriction and expansion of said main body portion bladdermeans.
 6. The device of claim 1, including a plurality of said cuffassemblies adapted to be attached to each extremity of the patient. 7.The device of claim 1, wherein said main body portion has an outer layerof restraint material being substantially more dimensionally stable thansaid bladder means and extending for the full longitudinal length andfull circumference of said main body portion; and a pouch materialforming the inside surface of said main body portion and extending forthe full longitudinal length and circumference of said main bodyportion.
 8. The device of claim 7, including a plurality of restrainttapes longitudinally spaced with respect to each other and extendingcircumferentially around said main body portion; and a plurality ofadditional restraint tapes circumferentially spaced from each other andextending for the full longitudinal length of said main body portion. 9.The device of claim 1, including slot means permitting the passage of acatheter radially through said main body portion to the arm area of thepatient opposite from the elbow; said slot means being a narrowlongitudinally aligned slot extending completely through said main bodyportion.
 10. The device of claim 9, including reinforcing meansextending externally completely around said slot; and binding meansextending completely externally around said slot, along all the innerwalls of said slot and continuously internally around said slot.
 11. Thedevice of claim 1, wherein said closure means includes a mitten-typebody forming a closure for one end of said body.
 12. The device of claim11, including fluid expandable bladder means extending at leastpartially circumferentially around said mitten and longitudinallythereof for exerting an inward pulsating pressure to the patient inresponse to being supplied pulsating fluid under pressure.
 13. Thedevice of claim 11, wherein said mitten has releasable fastener meanseXtending for substantially its full longitudinal length.
 14. The deviceof claim 13, wherein said mitten includes lacing means extending forsubstantially the full longitudinal length of said mitten and on eachside of said releasable fastener means, for manually constricting saidmitten in the circumferential direction.
 15. The device of claim 11,wherein said mitten includes a rigid plate longitudinally extendingalong one side and adapted to receive the sole or palm of the patient.16. The device of claim 1, wherein said main body portion bladder meansincludes a plurality of separate inflatable bags longitudinally spacedwith respect to each other and each circumferentially extending aroundthe full circumference of the main body portion.
 17. The device of claim16, wherein each of said inflatable bags has opposed overlapping ends,with the corresponding ends of all inflatable bags being longitudinallyaligned; and releasable fastener means for completely opening onelongitudinal side of said main body portion radially opposite from saidoverlapping ends of said inflatable bags.
 18. The device of claim 16,wherein each inflatable bag includes a separate fluid coupling; and saidexpandable chamber means including a separate fluid coupling.
 19. Thedevice of claim 16, including a plurality of longitudinally spaced andcircumferentially extending restraint tapes, with each tapelongitudinally alternating with said inflatable bags.
 20. The device ofclaim 16, including restraint material circumferentially extendingcompletely around and longitudinally along said main body portion toform its outer surface; pouch material circumferentially extendingaround and longitudinally along said main body portion to form its innersurface; a plurality of restraint tapes, each extendingcircumferentially along the outer surface of said restraint materialimmediately radially opposite the division between longitudinallyadjacent inflatable bags; a plurality of binding tapes circumferentiallyextending around the inner surface of said pouch material directlyradially opposite the division between longitudinally adjacentinflatable bags; each of said inflatable bags being formed of tworesilient sheets; respective ones of said restraint tapes, saidrestraint material, said resilient sheets, said pouch material, andrespective ones of said binding tapes being circumferentially bonded oneto the other at least along a common radially extending plane.
 21. Thedevice of claim 16, wherein each of said inflatable bags is constructedof only two resilient sheets bonded together along circumferential linesforming the division between longitudinally adjacent bags and togetheralong two longitudinal lines forming said overlapping ends.
 22. Thedevice of claim 21, including restraint material circumferentially andlongitudinally surrounding and forming the outer layer of said main bodyportion; a plurality of anchor tabs, each having one end secured to theinner surface of said restraint material and an opposite end secured toa respective one of said inflatable bags; a pouch materialcircumferentially extending and longitudinally extending to form theinner surface of said main body portion; a plurality of anchor tabs eachhaving one end secured to a respective one of said inflatable bags andan opposite end secured to said pouch material; all of said anchor tabsbeing located immediately radially of the division betweenlongitudinally adjacent inflatable bags.
 23. The device of claim 22,including a restraint tape circumferentially extending around said mainbody portion radially opposite each division between longitudinallyadjacent inflatable bags.